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临床试验/NCT06174610
NCT06174610招募中不适用

Changes of Renal Resistive Index in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy - Observational Study.

Uniwersytecki Szpital Kliniczny w Opolu1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Relationship between changes in RRI and recovery of kidney function

研究概览

简要总结

The aim of the study is to determine whether there is a correlation between changes in the renal resistive index and the restoration of kidney function in critically ill patients undergoing continuous renal replacement therapy.

详细描述

A significant number of critically ill patients experience acute kidney injury (AKI), an independent factor contributing to increased mortality. Prevention of AKI and monitoring kidney function are crucial. Commonly used markers such as serum creatinine and hourly diuresis are employed to assess AKI severity, but they are not ideal due to their late elevation in the disease course. Therefore, alternative methods for detecting and evaluating kidney dysfunction at an earlier stage are sought.

Previous studies have demonstrated a correlation between the risk of AKI and the resistive index of renal parenchymal arteries. Renal resistive index (RRI) is a parameter calculated from Doppler measurements, representing the difference between peak blood velocity during systole and end-diastolic velocity divided by peak systolic velocity [(Vs-Vd) /Vs]. In healthy adult kidneys, the RI typically ranges from 0.6 to 0.7. Changes in RRI can be observed much earlier than an increase in serum creatinine concentration and/or a decrease in hourly diuresis.

Some patients with acute kidney injury require renal replacement therapy. Continuous renal replacement therapy (CRRT) is commonly used in critically ill patients, causing less circulatory destabilization compared to intermittent therapies. However, adverse effects accompany renal replacement therapies, including thromboembolic complications, bleeding, infections, blood cell damage, altered drug pharmacokinetics, and loss of proteins and vitamins.

In addition to determining the appropriate initiation time for CRRT, identifying the optimal moment to end the treatment is crucial. CRRT is typically applied for several days, and during the procedure, it is challenging to ascertain whether renal function has improved and whether CRRT can be safely discontinued. The hypothesis is that there may be a correlation between changes in RRI and the recovery of kidney function. This may enable the early identification of patients who have regained kidney function, allowing for the earlier termination of CRRT.

In 1989, a study was conducted on children undergoing peritoneal dialysis due to AKI, showing a relationship between a decrease in RRI and the restoration of kidney function. However, no similar study has been conducted on adult patients undergoing continuous renal replacement therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All ICU patients undergoing CRRT due to AKI

排除标准

  • age <18 years
  • pregnancy
  • history of chronic kidney disease in stage 4 or 5
  • post-kidney transplant status
  • mechanical circulatory support
  • occurrence of one or more conditions preventing reliable RRI measurement in both kidneys:
  • challenging technical conditions of ultrasound examination, hindering proper visualization of the kidney
  • post-kidney injury in grade III and higher, according to AAST
  • advanced parenchymal kidney pathology: atrophy, hypoplasia, cirrhosis, extensive ischemia (more than 2/3 of the parenchyma),
  • kidney diseases preventing parenchyma identification: advanced cancer (stage above T1 according to TNM), certain forms of polycystic kidney disease
  • inflammatory kidney diseases
  • obstructive uropathy
  • renal vascular pathologies: renal vein thrombosis, significant stenosis (>60%), and renal artery occlusion.

结局指标

主要结局

Relationship between changes in RRI and recovery of kidney function

时间窗: on average from 1 to 3 weeks

The first ultrasound examination should be performed before the initiation of CRRT and, if not possible, within 24 hours of starting CRRT. Subsequently, the renal arteries will be assessed once a day during CRRT and after its completion until kidney function improves or there is a need for a return to renal replacement therapy. The return of kidney function is defined as a stable (increase \<0.3 mg/dl/24h) or decreasing serum creatinine level in two consecutive tests conducted at intervals of at least 24 hours and an average hourly diuresis \>0.5 ml/kg over the last 12 hours, with or without loop diuretics.

次要结局

未报告次要终点

研究者

发起方
Uniwersytecki Szpital Kliniczny w Opolu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maciej Piwoda

Principal Investigator

Uniwersytecki Szpital Kliniczny w Opolu

研究点 (1)

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